A First in Humans Study of Safety and Feasibility of baroloop: The baroloop Study
- Conditions
- hypertension10057166
- Registration Number
- NL-OMON54976
- Lead Sponsor
- neuroloop GmbH
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
• Aged 18 years or older and less than 80 years of age.
• Persistent office systolic blood pressure (SBP) >= 140 mm Hg or diastolic
blood pressure (DBP) > 90 mm Hg on antihypertensive medicines on two visits
separated by a minimum of four weeks.
• Mean 24-hour systolic ABPM >= 130 mm Hg and mean 24-hour diastolic ABPM >= 80
mm Hg conducted after direct observed therapy to confirm that antihypertensive
medicines were taken as prescribed during the ABPM measurement.
•. Stable drug regimen of 4 antihypertensive medicines consisting of a
renin-angiotensin blocker(ACE) or Angiotensin II Receptor Blocker (ARBs), a
calcium channel blocker (CCB), and a diuretic for 4 weeks at treatmenta
diuretic and spironolactone for 4 weeks at treatment. If spironolactone is not
tolerated, the regimen must include instead the addition of further diuretic
therapy with either eplerenone, amiloride, higher-dose thiazide/thiazide-like
diuretic or a loop diuretic, or the addition of bisoprolol or doxazosin. If
none of these medicines are tolerated, then patients on a 3-drug regimen may be
included.
. The Investigator has confirmed that the patient has already tried and/or is
not suitable for treatment with currently CE-marked device-based therapies for
resistant hypertension as an alternative to baroloop therapy.
• Negative pregnancy test for women of child-bearing age
• Willingness and ability to comply with follow-up requirements.
• Signed informed consent.
• Any patient in whom access to the vagal nerve is .limited by the size of the
vagus (a size not compatible with the baroloop cuff).
. Any patient with a history of injury to the vagus nerve or its branches
(e.g., the recurrent laryngeal nerve).
.
• Secondary causes of hypertension.
• Calculated eGFR < 30 mL/min/1.73m2.
• Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c
> 10%).
• One or more episodes of orthostatic hypotension in the past year
• Requirement for chronic oxygen therapy or mechanical ventilation.
• Untreated (no CPAP therapy) sleep apnea (AHI > 15)
• Morbid obesity, defined as Body Mass Index >40 kg/m2 or arm circumference 46
cm.
• Pacemaker and/or implantable defibrillators.
• History of transient ischemic accident or cerebrovascular accident during six
(6) months prior to screening.
• Symptomatic carotid artery disease or > 70% occlusion of either carotid
artery ; any carotid malformation or lesion, a carotid bruit or other abnormal
carotid sound.
. Prior surgery, radiation therapy or scarring in the neck in the region of the
carotid artery (e.g., patients with a tracheostomy, extensive thymectomy or
thyroid surgery).
. Limited mobility of the neck secondary to vertebral disease or prior
vertebral surgery, including patients who wear a cervical support.
• History of heart failure (NYHA class III-IV or ejection fraction < 30%),
myocardial infarction, unstable angina, coronary bypass or coronary angioplasty
during six (6) months prior to screening.
• Cardiac arrythmias (atrial fibrillation, atrial flutter, etc.) that require
anticoagulation or interfere with a consistent measurement of blood pressure.
women of childbearing age are excluded for participation in this trial
• Syncope in the last 6 months.
• History of bleeding disorders, thrombocytopenia, hemophilia or significant
anemia (hemoglobin (Hgb) < 10 gm/dl).
• Current anticoagulation therapy (excluding antiplatelet therapy with aspirin
as a sole therapy).
• Works night shifts.
• History of unresolved drug or alcohol use.
• Active treatment of a psychiatric ailment.
• Life expectancy of less than 12 months due to other disease.
• Subject has a condition that, in the opinion of the investigator, precludes
participation, including willingness to comply, with all follow-up procedures.
• Participation in another clinical study for which follow-up is currently
on-going.
. Baroreflex failure or autonomic neuropathy
. Symptomatic, uncontrolled bradyarrhythmias
. Atrioventricular block of any grade
. Patients who are treated with Pacemaker and/or implantable defibrillators
. Presence of a vagus stimulator
. Patients who expect to require magnetic resonance imaging (MRI) of the
cervical area
. Occupational exposure to high levels of non-ionizing radiation that may
interfere with therapy
. Patients with a limited ability to read, understand and execute adjustment
procedures (for example, persons suffering from dementia).
. Likely exposure to diathermy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>4.2. Primary Study Endpoints<br /><br>4.2.1. Safety<br /><br>Composite Major Adverse Event (MAE) Rate at six (6) months post-treatment<br /><br>including:<br /><br>• All-causes of death<br /><br>• Hospitalization for hypertensive crisis post-titration<br /><br>• Any device or procedure-related serious adverse event<br /><br>All MAEs will be adjudicated by an independent Data Safety Management Board<br /><br>(DSMB)<br /><br><br /><br>4.2.2. Feasibility<br /><br>The ability of the baroloop System to be placed around a vagal nerve and to<br /><br>stimulate at Day14/21 post-implantation. . </p><br>
- Secondary Outcome Measures
Name Time Method